The Management of Schizophrenia in Clinical Practice (MOSAIC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01746134
First received: December 4, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This study is a disease-based registry designed to follow patients with a DSM-IV

-TR (Diagnostic and Statistic Manual of Mental Disorders, Text Revision) diagnos is of schizophrenia, schizoaffective disorder, or schizophreniform disorder trea ted in usual care settings for up to 5 years. The registry seeks to describe the course of disease in schizophrenia, including cognitive function and negative s ymptoms, its treatment, and its burden of disease for participants, caregivers, clinicians, and society as a whole.


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-Interventional Registry of Diverse Patients With Schizophrenia Across the Disease Spectrum in Usual Care Settings: Course of Disease, Treatments, and Burden of Illness

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Positive and Negative Symptoms of Schizophrenia (PANSS) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Clinical Global Impression Schizophrenia Scale (CGI-SCH) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Cognitive function (Fluency, Digit Symbol-Coding, Trail Making Test) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Negative Symptom Assessment Scale (NSA4) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Pharmacologic/behavioural treatments used in usual care settings: intervention [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Pharmacologic/behavioural treatments used in usual care settings: dose [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Pharmacologic/behavioural treatments used in usual care settings: duration [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Personal and Social Performance (PSP) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Schizophrenia Quality of Life Scale (SQLS) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Schizophrenia Caregiver Questionnaire [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Maslach Burnout Inventory (MBI) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 557
Study Start Date: December 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with schizophrenia, schizoaffective disorder, or schizophreniform across the disease spectrum treated in usual care settings

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder
  • Participants presenting with the normal course of care in usual treatment settings
  • Able to read and speak English
  • Able and willing to provide informed consent
  • Able and willing to comply with the study protocol

Exclusion Criteria:

  • Participants enrolled as subjects in clinical trials at registry enrollment
  • Participants anticipating they will be unable to participate in regularly scheduled assessments as per protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746134

  Show 44 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01746134     History of Changes
Other Study ID Numbers: ML28264
Study First Received: December 4, 2012
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 23, 2014